If I send a No Change SPL to eList, will it automatically validate against DUNS numbers, addresses, or other fields that have had validation rules applied recently?
Answer:
The submission of a No Change Notification SPL does not revalidate the previous ER SPL.
If there is an error or a change, the sponsor (registrant) should send the entire Establishment Registration SPL
document.
Reference(s) :
Question to SPL@fda.hhs.gov
[11-Nov 2008]
Subject:
Changes to Establishment Registration Data
Question:
If I have a change to the only one of my establishments, can I delete the rest of the establshments from the ER SPL (since they have no changed information)?
Answer:
Make the change to the Establishment information being modified. Leave in the other Establishments. If they are removed, their information will be deleted from the Establishment Registry.
Reference(s) :
DIA Meeting Oct 29-30.
[11-Nov 2008]
Subject:
API Registration and Application Number
Question:
What application number, if any, do I add?
Answer:
Include the Drug Master File ID number when available.
Reference(s) :
DIA Meeting Oct 29-30.
[24-Nov 2008]
Subject:
Repackager and Establishment Registration Data
Question:
I am a repacker (repackager). If I do not know the DUNS number for an establishment, what do I enter?
Answer:
Include the NDC Product Code -- the first two sections of the NDC -- in the Source NDC Product Code field.
Reference(s) :
DIA Meeting Oct 29-30.
[08-Dec 2008]
Subject:
US Agent and DUNS Number
Question:
Does a US Agent have to get a DUNS number? Does a US Agent use the DUNS number of their company?
Answer:
The DUNS Number is assigned to the company or organization. The US Agent is an individual doing business as (d/b/a) that company or organization.
Reference(s) :
DIA Meeting Oct 29-30.
[08-Dec 2008]
Subject:
Paper Notification of Establishment Registration
Question:
Will the sponsor receive any kind of paper notification that the FDA received an Establishment Registration?
Answer:
The current expectation is that the FDA website will have the listing, and that a paper notification will not be sent to the sponsor.
[16-Dec 2009]
Subject:
No Change SPLQuestion:
If I send a No Change SPL to eList, will it automatically validate against DUNS numbers, addresses, or other fields that have had validation rules applied recently?Answer:
The submission of a No Change Notification SPL does not revalidate the previous ER SPL.If there is an error or a change, the sponsor (registrant) should send the entire Establishment Registration SPL
document.
Reference(s) :
Question to SPL@fda.hhs.gov[11-Nov 2008]
Subject:
Changes to Establishment Registration DataQuestion:
If I have a change to the only one of my establishments, can I delete the rest of the establshments from the ER SPL (since they have no changed information)?Answer:
Make the change to the Establishment information being modified. Leave in the other Establishments. If they are removed, their information will be deleted from the Establishment Registry.Reference(s) :
DIA Meeting Oct 29-30.[11-Nov 2008]
Subject:
API Registration and Application NumberQuestion:
What application number, if any, do I add?Answer:
Include the Drug Master File ID number when available.Reference(s) :
DIA Meeting Oct 29-30.[24-Nov 2008]
Subject:
Repackager and Establishment Registration DataQuestion:
I am a repacker (repackager). If I do not know the DUNS number for an establishment, what do I enter?Answer:
Include the NDC Product Code -- the first two sections of the NDC -- in the Source NDC Product Code field.Reference(s) :
DIA Meeting Oct 29-30.[08-Dec 2008]
Subject:
US Agent and DUNS NumberQuestion:
Does a US Agent have to get a DUNS number? Does a US Agent use the DUNS number of their company?Answer:
The DUNS Number is assigned to the company or organization. The US Agent is an individual doing business as (d/b/a) that company or organization.Reference(s) :
DIA Meeting Oct 29-30.[08-Dec 2008]
Subject:
Paper Notification of Establishment RegistrationQuestion:
Will the sponsor receive any kind of paper notification that the FDA received an Establishment Registration?Answer:
The current expectation is that the FDA website will have the listing, and that a paper notification will not be sent to the sponsor.Reference(s) :
DIA Meeting Oct 29-30.